Assoc Dir GPS Quality & Compliance
Full time
at Regeneron Pharmaceuticals, Inc
in
Online
Posted on May 8, 2024
Job details
- Dublin, Ireland / Remote - Ireland / Uxbridge, Middlesex, United Kingdom / Remote - United Kingdom
- Develop and execute a compliance and quality oversight governance for GPS Safety Sciences deliverables including, but not limited to, Risk Management Plans, Signal Management, and the Pharmacovigilance System Master File.
- Establish and refine key performance indicators to ensure overall quality and compliance with associated with GPS Safety Science deliverables.
- Liaise with GPS subject matter experts, Regulatory Affairs, Medical Affairs and other key functions on key performance indicators and proactively identify potential trends or significant non-compliance.
- Conduct Global Patient Safety-related non-compliance investigations for minor events including trending and support investigation and CAPA implementation of any significant quality events based on established documented procedures associated with benefit-risk deliverables.
- Provide support, for quality review of additional GPS deliverables, including but not limited to, Safety Agreements and Safety Management Plans.
- Support GPS-related audits and inspections.
- As needed, assist in review and contribution to Global Patient Safety Quality and Compliance-related documented procedures.
- Effectively manage workload to independently ensure overall compliance with standards and timelines.
- Work effectively with other Global Patient Safety sub-functions, Contract Research Organization, Vendors, and relevant personnel to discuss issues and identify timely solutions.
- Participate in the continuous process improvement effort within the function to identify gaps and advise management accordingly.
- Responsible for management of assigned Quality & Compliance staff as applicable; this includes but is not limited to management of job performance, career development and training.
- Good communication skills, both written and verbal.
- Ability to multi-task and effectively manage demanding timelines.
- Ability to work collaboratively across functions and roles.
- High level of accountability; drive results.
- Strong understanding of global safety reporting regulations and guidelines including FDA, ICH, and GVP.
- Strong computer skills and experience working with the Microsoft programs (Word, Excel, PowerPoint, Outlook).
- Knowledge of medical concepts and terminology.
- Familiarity with data analytics platforms.
- Strong knowledge of safety database.
- Bachelor's Degree, minimum 10-years pharmacovigilance-related experience, healthcare professional preferred.
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